OTC - ACTIVE INGREDIENT SECTION
Titanium Dioxide 8%
Zinc Oxide 3.8%
TiZO3 - Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
- Manufacturer
- Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
- Effective date
- 2026-04-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:34
Label at a glance#
ProductTiZO3
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Sunscreen
INDICATIONS & USAGE SECTION
Helps Prevent Sunburn. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.
WARNINGS SECTION
For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
INACTIVE INGREDIENT SECTION
Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate
OTHER SAFETY INFORMATION
- Protect this product from excessive heat and direct sun
- May stain some fabrics
- PA+++
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-326-85 | TiZO3 | 85 mL in 1 BOTTLE, PUMP | CREAM | 85 | 1 |
Products#
Every source-derived product name is available through these pages.
- TiZO3
- Titanium Dioxide, Zinc Oxide
- HYDROGEN DIMETHICONE (20 CST)
- CYCLOHEXASILOXANE
- DIMETHICONE CROSSPOLYMER
- TETRAHEXYLDECYL ASCORBATE
- CYCLOPENTASILOXANE
- DIMETHICONOL (2000 CST)
- CI 77499
- TITANIUM DIOXIDE
- CI 77491
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- CI 77492
- DIMETHICONE
- ALPHA-TOCOPHEROL ACETATE
- ZINC OXIDE
- LAURYL PEG/PPG-18/18 METHICONE
- PEG-10 DIMETHICONE (600 CST)
- ALUMINA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-326 | 58892-326-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | 58892-326-85 58892-326 58892032685 4e7bdec2-abcd-0267-e063-6394a90ae47a 4e7bdec2-abcc-0267-e063-6394a90ae47a |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 468d6476-127a-e9f0-e063-6294a90a3df9 | 2025-12-22 | Warnings | 58892-326 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.